Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00936221
First received: July 8, 2009
Last updated: November 4, 2015
Last verified: November 2015
  Purpose
To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Condition Intervention Phase
Melanoma
Drug: AZD2644
Drug: Dacarbazine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Double-blind, Randomised Study to Assess the Efficacy of AZD6244 in Combination With Dacarbazine Compared With Dacarbazine Alone in First Line Patients With BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Randomzation to data cutoff ] [ Designated as safety issue: No ]
    Time from randomization to death due to any cause


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Randomization to data cutoff ] [ Designated as safety issue: No ]
    Time from randomization to objective disease progression, according to RECIST 1.0, or death.

  • Objective Response Rate [ Time Frame: randomization up to and including PFS event ] [ Designated as safety issue: No ]
    Patients classified as a responder have a best response of partial response of complete response as per RECIST 1.0

  • Change in Target Lesion Tumour Size at Week 12 [ Time Frame: randomization to week 12 ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: July 2009
Study Completion Date: November 2014
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AZD6244 in combination with dacarbazine
Drug: AZD2644
oral capsules, 75mg twice daily
Drug: Dacarbazine
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Other Name: DTIC
Placebo Comparator: 2
Placebo in combination with dacarbazine
Drug: Dacarbazine
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Other Name: DTIC
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 130 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological confirmation of advanced (inoperable stage III and stage IV) cutaneous or unknown primary melanoma
  • Tumor sample confirmed as BRAF mutation positive

Exclusion Criteria:

  • Diagnosis of uveal or mucosal melanoma
  • Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK
  • Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936221

  Hide Study Locations
Locations
United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
Brazil
Research Site
Belo Horizonte, Brazil
Research Site
Ijuí, Brazil
Research Site
Porto Alegre, Brazil
Research Site
Sao Paulo, Brazil
Czech Republic
Research Site
Brno, Czech Republic
Research Site
Novy Jicin, Czech Republic
Research Site
Praha 2, Czech Republic
France
Research Site
Lille Cedex, France
Research Site
Marseille, France
Research Site
Villejuif Cedex, France
Germany
Research Site
Berlin, Germany
Research Site
Essen, Germany
Research Site
Hannover, Germany
Research Site
Kiel, Germany
Research Site
Tübingen, Germany
Hungary
Research Site
Budapest, Hungary
Research Site
Györ, Hungary
Research Site
Székesfehérvár, Hungary
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Norway
Research Site
Oslo, Norway
Spain
Research Site
Barcelona, Spain
Research Site
Houston, Spain
Research Site
Málaga, Spain
Research Site
Palma de Mallorca, Spain
Sweden
Research Site
Göteborg, Sweden
Research Site
Malmö, Sweden
Research Site
Stockholm, Sweden
Switzerland
Research Site
Zürich, Switzerland
United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Chelmsford, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle upon Tyne, United Kingdom
Research Site
Oxford, United Kingdom
Research Site
Sutton, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Mark Middleton, Dr Churchil Hospital, Oxford, UK
Principal Investigator: Caroline Robert, Dr Institute Gustave Roussy, France
Study Director: Ian Smith, Dr AstraZeneca, Alderley Park, UK
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00936221     History of Changes
Other Study ID Numbers: D1532C00006 
Study First Received: July 8, 2009
Results First Received: November 4, 2015
Last Updated: November 4, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
BRAF mutation positive
advanced melanoma
Advanced cutaneous melanoma
Unknown primary melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on February 07, 2016